Daewoong Pharmaceutical has achieved a significant breakthrough in obesity treatment delivery with its microneedle patch demonstrating over 80% relative bioavailability for semaglutide, marking the highest reported performance for this drug delivery method and potentially transforming how patients receive this blockbuster therapy.
The pilot human pharmacokinetic study involved 70 healthy adults who received either a single dose of semaglutide via subcutaneous injection or through Daewoong's microneedle patch. The patch's bioavailability far exceeded the approximately 30% achieved by existing microneedle patches and showed around 160 times higher bioavailability than semaglutide oral tablets.
Superior Performance Across Multiple Metrics
The study results revealed that therapeutic plasma levels were maintained over seven days, highlighting the patch's potential for once-weekly dosing comparable to Novo Nordisk's injectable Wegovy. This performance profile matches that of the injectable counterpart while eliminating the need for needles.
"Microneedle formats have long promised better adherence, but high-dose delivery has been a challenge," said Seong-Soo Park, CEO of Daewoong Pharmaceutical. "This work is the first to overcome that barrier. We plan to expand microneedle technology to a wide range of biologics to lead the global platform market."
The patch addresses significant limitations of current semaglutide formulations. While oral semaglutide tablets are available, they require complex medication regimens including fasting before dosing, limiting water intake, and avoiding co-administration with other drugs, potentially lowering adherence among chronic patients.
Advanced Technology Platform
The breakthrough was enabled by Daewoong Therapeutics' patented CLOPAM® (CLOsed Packed Aero-pressured Microneedle) platform, a dissolving-type microneedle technology designed for precise, skin-based drug delivery. The platform uses pressurized drying and hermetic packaging to improve drug uniformity and stability, allowing accurate dosing with minimal contamination risk.
Unlike injectable semaglutide products that require cold-chain storage, Daewoong's patches remain stable at room temperature, potentially reducing distribution costs and medical waste from syringes and needles. The CLOPAM® platform currently has 52 patent filings worldwide.
"The microneedle patch must achieve not only high bioavailability but also a drug load sufficient for therapeutic effect," said Bok-Ki Kang, CEO of Daewoong Therapeutics. "In this study, we incorporated a high dose of semaglutide into a single patch and showed the potential for once-weekly application. This overcomes a key limitation of previous microneedle approaches and provides a strong foundation for global technology transfer and commercialization."
Market Impact and Future Prospects
The innovation comes at a critical time for the obesity therapeutics market, valued at $15.9 billion in 2024 and projected to reach $60.5 billion by 2030 according to Grand View Research. With therapeutic and safety advantages in the GLP-1 drug class becoming limited, experts expect delivery technologies that improve both bioavailability and patient convenience will determine future market leaders.
The microneedle patch approach could expand treatment access to patients who avoid injections while maintaining the efficacy of current injectable therapies. Based on these results, Daewoong Therapeutics is planning to broaden collaborative initiatives to the global market through technology licensing, co-development, and out-licensing to prepare for commercialization.
